FDA: Page 20
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Alnylam wins FDA approval of rare disease drug in step toward profitability
Amvuttra, a transthyretin amyloidosis medicine previously known as vutrisiran, is viewed by biotech analysts as important to the company’s goal of ending years of financial losses.
By Ben Fidler • Updated June 14, 2022 -
Courtesy of Pfizer
FDA staff supportive of Pfizer, Moderna COVID vaccines in young children
Agency advisers will weigh data from the companies at a two-day meeting that begins Tuesday with discussion of Moderna’s shot in children and teens aged 6 to 17 years old. Use in kids under 5 will be debated Wednesday.
By Jonathan Gardner , Ned Pagliarulo • June 13, 2022 -
Permission granted by Bluebird bio
FDA advisers offer unanimous support to second Bluebird gene therapy
By a 13-0 vote, the panel agreed the benefits of Bluebird’s beta thalassemia treatment outweigh its risks, one day after reaching a similar conclusion for another of the company’s drugs.
By Ned Pagliarulo • Updated June 10, 2022 -
Courtesy of Novavax, Australian Broadcasting Corporation
FDA advisers back Novavax's latecomer COVID-19 vaccine
Outside experts debated the shot's safety profile and its efficacy versus the omicron variant but ultimately supported the vaccine, which is made using more traditional technology than Pfizer's and Moderna's.
By Jonathan Gardner • Updated June 7, 2022 -
Getty Images
FDA extends review of Amylyx ALS drug, delaying approval decision
The agency said it wanted more time to assess additional clinical trial data submitted by Amylyx, and set a new decision date of Sept. 29 for the closely watched treatment.
By Ned Pagliarulo • June 3, 2022 -
Courtesy of Pfizer
Pfizer says 3 doses of its COVID-19 vaccine works in youngest children
The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.
By Jonathan Gardner • May 23, 2022 -
Permission granted by Gilead Sciences
Gilead, having resolved manufacturing issues, forges ahead with HIV drug
The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.
By Jacob Bell • May 17, 2022 -
Courtesy of Eli Lilly
Lilly wins FDA approval for new kind of diabetes drug
Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and was shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.
By Jonathan Gardner • Updated May 16, 2022 -
Sarah Silbiger via Getty Images
BridgeBio sale of FDA voucher good news for Bluebird, other biotech sellers
The drugmaker was able to get $110 million for its voucher, a kind of regulatory fast pass. Other vouchers have sold for similar amounts, boding well for Bluebird, which plans to sell two that it hopes to get this year.
By Ned Pagliarulo • May 13, 2022 -
Sarah Silbiger via Getty Images
With spotlight on FDA, Congress weighs reforms to accelerated drug approvals
The proposed changes could have a notable impact on cell and gene therapy developers, many of which are advancing rare disease therapies that rely on speedy approval pathways.
By Jonathan Gardner • May 10, 2022 -
Getty Images
Sponsored by CorEvitasTraditional and bespoke registries
In order to truly understand the lived experience of a patient with a given condition or disease, several types of real-world data sources should be analyzed.
May 9, 2022 -
Jon Cherry via Getty Images
FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect
The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.
By Ben Fidler • May 6, 2022 -
Jacob Bell/BioPharma Dive
AstraZeneca and Daiichi set to broaden use of breast cancer drug, challenging Roche
The FDA cleared Enhertu for second-line use in HER2-positive disease, the latest inroads the partners have made against Roche’s dominant portfolio of breast cancer medicines.
By Ben Fidler • May 5, 2022 -
Getty Images
Spero to lay off 75% of workforce, change strategy after FDA challenges study results
Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring.
By Ben Fidler • May 4, 2022 -
Sarah Silbiger via Getty Images
FDA rejects two China-developed cancer drugs
The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine.
By Jonathan Gardner • May 2, 2022 -
Getty Images
Sponsored by CorEvitasUnderstanding real-world data in the real world
Real-world data (RWD) and real-world evidence (RWE) are valuable across the entire pharmaceutical product lifecycle, from examining patient outcomes to supporting disease education and awareness and beyond.
May 2, 2022 -
Sergio Flores via Getty Images
Moderna seeks FDA clearance for COVID-19 vaccine in young children
The biotech's shot would become the first available to children under 6, the last remaining age group currently ineligible for vaccination.
By Kristin Jensen • April 28, 2022 -
Sarah Silbiger via Getty Images
FDA panel supports agency push to raise approval bar for certain cancer drugs
Though agency advisers were hesitant to label an entire drug class, they backed the FDA's interest in demanding randomized trials of PI3 kinase-blocking drugs, a decision that could impact future research.
By Jonathan Gardner • April 22, 2022 -
Sarah Silbiger via Getty Images
GSK to test FDA's tough stance on anemia pills
Unlike treatments from Akebia and FibroGen, GSK's drug hasn't been tied to a higher risk of heart problems, potentially easing the agency's concerns.
By Ben Fidler • April 19, 2022 -
Jacob Bell/BioPharma Dive
Troubling data leads a biotech to pull its prized drug from market and FDA review
Early analysis of a key clinical trial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.
By Jacob Bell • April 18, 2022 -
Courtesy of Pfizer
Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds
A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.
By Kristin Jensen • April 14, 2022 -
Justin Sullivan via Getty Images
FDA clears Gilead to restart some studies of top cancer drug
The agency's OK is a needed reprieve for Gilead, whose dealmaking strategy in oncology has come under scrutiny from analysts and investors.
By Ben Fidler • April 12, 2022 -
Sarah Silbiger via Getty Images
'Where's the patient?': Experts question FDA's device recall guidance
While the guidance encouraged the use of electronic communications in recalls — a change experts have advocated for — some questioned why the agency did not address more problems with the system.
By Ricky Zipp • April 6, 2022 -
Sergio Flores via Getty Images
FDA advisers grapple with how to update COVID-19 vaccines
About half of eligible Americans haven't received a booster and may be less protected should cases surge. Health officials hope to soon ready an updated shot, but experts on the committee struggled to identify the best approach.
By Ned Pagliarulo • Updated April 7, 2022 -
Sarah Silbiger via Getty Images
FDA halts Vir, GSK antibody use in response to COVID subvariant's spread
The COVID-19 treatment had a brief time in the spotlight as one of the few drugs that's potent against the omicron variant. A substrain called BA.2 is now dominant in the U.S., however.
By Kristin Jensen • April 6, 2022
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